NCT06450158

Robot-assisted Training in Children With CP

Robot-assisted Hand Training to Induce Manual Functional Change and Cerebral Neural Plasticity in Children With Cerebral Palsy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cook Children's Health Care System · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Cerebral palsy (CP) is the most common physical disability in early childhood causing serious motor and sensory impairments. Effective interventions for the recovery of motor functions are of profound significance to children with CP, their families, caregivers, and health professionals. Robot-assisted rehabilitation represents a frontier with potential to improve motor functions and induce brain reorganization in children with CP.

Detailed description

This study is designed to test whether robot-assisted hand training with Amadeo improves manual functions and induces cerebral neural plasticity in children with CP. To evaluate the efficacy of the robot-assisted hand training, investigators will measure manual motor and sensory functions with behavioral tasks and assess neural activities in the sensorimotor cortical network with high-density electroencephalography (HD-EEG) and transcranial magnetic stimulation (TMS) one day before, one day after, and two months after the robot-assisted training. The study will provide direct evidence on the effectiveness of the robot-assisted training in recovering of manual functions in children with CP. It will provide detailed insights on potential experience-dependent neuraplastic changes in the brain of children with CP. It has the potential to insight the development of more effective rehabilitation for children with CP and also children with other neurological disorders, like pediatric stroke. It may uncover factors that will be predictive of functional improvements in individual CP patient.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	Robot (Amadeo)-assisted Training	Amadeo® is an FDA Class I Exempt hand/finger robot that has the capacity to precisely measure hand/finger functions. To use Amadeo, a participant will be seated in a chair. The height of the robot arm support will be adjusted to achieve a comfortable position for the participant. One of the participant's arms will be will be placed on the robot arm support. Magnetic finger tips will then be attached to fingers and thumb. After this, fingers and thumb will be connected to the robot finger sliders. To use Amadeo, the movement range and maximal force of each finger will be configured according to the finger's capability. The following four types of function assessments will be performed with Amadeo: Force, range of motion, tone, and spasticity. Each session will last approximately one hour.

Timeline

• Start date: 2021-09-25
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study